"ADAPT" The Adaptation to High Fat Diets Extention
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|ClinicalTrials.gov Identifier: NCT00493701|
Recruitment Status : Active, not recruiting
First Posted : June 28, 2007
Last Update Posted : January 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Behavioral: High Fat Diet Behavioral: Low Fat Diet||Not Applicable|
In the past 3 years we have identified a "thrifty-phenotype" characterized in lean men by an inability to adapt rapidly to a high fat diet and associated with a low maximal VO2 and high fasting insulin. We hypothesize that the individuals with the "thrifty phenotype" are at higher risk for becoming obese, and that exercise may be effective in overcoming this problem.
Several questions remain to be answered regarding the "thrifty" phenotype. First, given the large interindividual differences, how can we identify those at the highest risk? What are the distinguishing biochemical, endocrine and environmental characteristics of individuals that store fat when exposed to high fat diets? This is important because if these individuals can be easily identified, then dietary interventions can be targeted to this "at-risk" population.
Second, what is different about the individual with the "thrifty phenotype"? Are there cellular pathways that are dysregulated in the skeletal muscle of these individuals when compared to controls? Is the defect intrinsic, i.e. a diminished ability to conserve glucose and oxidize fat in skeletal muscle or alternately, is the phenotype due to environmental, and dietary factors such as inactivity and energy excess?
To answer these questions, we have planned a three-year project that aims to:
- Characterize the biochemical, endocrine, anthropometric and environmental characteristics of individuals with the "thrifty" phenotype.
- Identify the signaling pathways in skeletal muscle that are dysregulated in individuals with the "thrifty" phenotype through mRNA expression profiling in skeletal tissue.
- Determine the role of environmental factors such as inactivity and caloric intake vs. intrinsic (genetic) factors in the "thrifty" phenotype.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||ADAPT-The Adaptation to High Fat Diets|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Measurement of body weight in a fown with light undercloting (30 minutes) and height.
Behavioral: High Fat Diet
Other Name: Measurements will be collected to help with gathering data.
Low-dose X0rays to determine the amount of fat, bone and muscle in your body.
Behavioral: Low Fat Diet
Life style eating habits
Other Name: Questionnairs of food frequency
- Characterize the biochemical, endocrine, anthropometric and environmental characteristics of individuals with the "thrifty" phenotype. [ Time Frame: 4 days of high fat diet ]
- Identify the signaling pathways in skeletal muscle that are dysregulated in individuals with the "thrifty" phenotype through mRNA expression profiling in skeletal tissue. [ Time Frame: 4 days after high fat diet ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00493701
|United States, Louisiana|
|Pennington Biomedical Research Center|
|Baton Rouge, Louisiana, United States, 70808|
|Principal Investigator:||Steven R Smith, M.D.||Pennington Biomedical Research Center|